A congressional finding that a drug company paid a National Institutes ofHealth (NIH) scientist for spinal fluid samples has raised a largerquestion: What happens to NIH's archived patient samples? NIH's efforts toimprove practices within its intramural program come as U.S. medical centersare trying to tighten controls over such materials.

At a 2-day hearing last week, Joe Barton (R-TX), chair of the House Energyand Commerce Committee, complained about the "lack of a centralized database[for patient samples] and a lack of oversight at NIH that could, andprobably does, leave NIH laborator[ies] vulnerable to the risks of theft andabuse." NIH officials testified they have already begun to improve theirprocedures.

But outside scientists agree with NIH that the agency needs time to organizeits millions of stored specimens. "People have their samples everywhere,"with details recorded on everything from paper notepads to computers, saysMark Sobel, a former NIH researcher who is now executive officer of theAmerican Society for Investigative Pathology. Creating a central registry ofNIH's holdings, he predicts, "is going to be a massive undertaking."

Barton's ethics investigation is an extension of an earlier one questioninglarge payments from drug companies to senior NIH scientists. That led NIH toban industry consulting by its intramural scientists last August (Science, 2September 2005, p. 1469). Last week's hearing focused on Alzheimer's diseaseresearcher Trey Sunderland of the National Institute of Mental Health (NIMH)and his dealings with drug giant Pfizer.

The committee pursued a complaint from Susan Molchan, a former clinicalresearcher in Sunderland's lab, that Sunderland wouldn't provide her withsome of her old spinal fluid samples. Staffers eventually learned thatSunderland had sent Pfizer about 3200 spinal fluid samples and 388 plasmasamples he and others had collected since the early 1980s, including somefrom Molchan, along with clinical data, from Alzheimer's patients andcontrols. The company used them to study so-called biomarkers, proteins thatmight serve as indicators for the neurodegenerative disease.

Pfizer had signed a Material Transfer Agreement with NIMH for the samples inApril 1998. Around the same time, Sunderland signed a consulting agreementwith Pfizer that eventually paid him $285,000. A 26-page bipartisan reportreleased last week by the Commerce Committee's oversight and investigationssubcommittee found "reasonable grounds to believe" that Pfizer made thepayments in exchange for the samples. Neither this agreement nor others withPfizer, for which Sunderland was paid more than $300,000 over several years,were reported to NIH.

CREDIT: CHRISTINE MCCARTYAt the hearing, NIH officials said the transfer and consulting agreementswould not have been approved because they improperly mixed official dutieswith consulting. "You could have both collaboration and consulting [but not]with the same agent," said NIMH Director Thomas Insel. Insel said Sunderlandinstead should have organized a cooperative agreement with the company forwhich he would not have been paid.

Sunderland and a co-worker, Karen Putnam, invoked their constitutional rightto decline to answer questions before the committee. Sunderland has saidthat his staff simply failed to complete the proper paperwork, and hisattorney Robert Muse says that "there is no truth to the allegation that Dr.Sunderland received a penny from Pfizer for the samples." NIH investigatorsearlier found that Sunderland had committed serious misconduct, and Inselsuggested to the U.S. Public Health Service Commissioned Corps that he beterminated. The corps has put his retirement on hold, however, and theDepartment of Health and Human Services Inspector General's office and theDepartment of Justice are still investigating.

The committee's report also questions whether Sunderland had obtained properinformed consent from some patients for the Pfizer study. NIH officials toldthe subcommittee that they have tightened rules on the sharing of humantissues, including adding a requirement that investigators describe futureplans for samples to an Institutional Review Board (IRB). In the mid-1990s,the policy was "very general," Insel said.

Indeed, a decade ago, researchers themselves often decided the fate ofleftover samples, says bioethicist Mark Rothstein of the University ofLouisville in Kentucky. Since bioethics council and other U.S. andinternational advisory bodies have called for better controls on the use ofstored human tissue (Science, 18 December 1998, p. 2165). Reviews of oldcollections have revealed that informed consent forms are often missing,leaving IRBs to decide whether samples can be used, Rothstein says: "It'sbeen a revelation."

But NIH officials say they need more time to figure out whether a centraldatabase of tissue specimens would make sense for the intramural program.The agency is looking at combining a new campuswide database of clinicaltrials with sample barcoding systems, says NIH Deputy Director forIntramural Research Michael Gottesman. And although extramural researchershave also traditionally tracked their samples individually, NIH's largestinstitute, the National Cancer Institute, is encouraging cancer centers totally their tumor specimens in databases so sharing will be easier.

Insel warned that moving toward a central system too quickly could add"speed bumps" to the scientific process. Legislators haven't said if theyplan to require a central database.